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FDA 510(k) Application Details - K972442
Device Classification Name
System, X-Ray, Fluoroscopic, Image-Intensified
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510(K) Number
K972442
Device Name
System, X-Ray, Fluoroscopic, Image-Intensified
Applicant
CONTINENTAL X-RAY CORP.
2000 SOUTH 25TH AVE.
BROADVIEW, IL 60153 US
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Contact
OSCAR KHUTORYANSKY
Other 510(k) Applications for this Contact
Regulation Number
892.1650
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Classification Product Code
JAA
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More FDA Info for this Product Code
Date Received
06/30/1997
Decision Date
09/11/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
RA - Radiology
Review Advisory Committee
RA - Radiology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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